Biatain Ibu vs. Biatain in Painful Chronic Venous Leg Ulcers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00627094
Recruitment Status : Completed
First Posted : February 29, 2008
Results First Posted : February 7, 2017
Last Update Posted : September 15, 2017
Information provided by (Responsible Party):
Coloplast A/S

Brief Summary:
The objective of this investigation is to demonstrate the effectiveness and safety of Biatain Ibu non-adhesive foam dressing compared to Biatain non-adhesive foam dressing.

Condition or disease Intervention/treatment Phase
Leg Ulcers Device: Biatain Device: Biatain Ibu Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Controlled and Double-blind Clinical Investigation on the Effectiveness and Safety of a Foam Dressing Biatain Ibu Non-adhesive vs. Biatain Non-adhesive, in Painful Chronic Venous Leg Ulcers
Study Start Date : March 2008
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Biatain Ibu
Biatain Ibu
Device: Biatain Ibu
Biatain Ibu non-adhesive (Coloplast A/S), a polyurethane foam dressing with an elastic semi-permeable backing film with an added pain relieving medicinal substance ibuprofen (Albermarle Inc.), size 15x15 cm. The product is CE marked.
Other Name: Coloplast Biatain-Ibu

Active Comparator: Biatain
Device: Biatain
A standard polyurethane foam dressing Biatain non-adhesive (Coloplast A/S) with an elastic semi-permeable backing film, size 15x15 cm. The product is CE marked.
Other Name: Coloplast Biatain

Primary Outcome Measures :
  1. Pain Relief [ Time Frame: Pain relief (morning/evening) after start of treatment from day 1 (evening) to day 5 (morning) ]
    The distribution of pain relief assesment during day 1 to 5. The pain relief was registrated on 5-point verbal rating scales (evening/morning) from day 1 to day 5 after start of treatment.

Secondary Outcome Measures :
  1. Pain Intensity (PI) Change [ Time Frame: Change from baseline in Pain Intensity (PI) on day 4 evening ]
    Pain intensity (PI) assesment performed daily during the days 1-5. Pain intensity assesment performed on a 11 point numerical box scale: 0 was no pain and 10 was worst possible pain. A positive outcome measure value (PI (baseline) - PI (day 4 evening)) means that PI has decreased since baseline and thus reflects clinical improvement (patients suffer less from pain).

  2. Change From Baseline in Ulcer Area [ Time Frame: Change from baseline to end of trial (day 43) ]
    Relative change from baseline in ulcer area using last observation carried forward. A positive outcome value Means that wound size has decreased and thus reflects wound healing (clinical improvement)

  3. Adverse Events [ Time Frame: Continuously from start of treatment to end of trial (day 43) ]
    Number of Adverse events reported which were evaluated to be related or possible related to the device

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • >= 18 years of age
  • Chronic venous leg ulcer on the lower leg
  • Ulcer duration >= 8 weeks
  • Pain intensity in study ulcer at least 4 on an 11-point numerical box scale (NBS): 0= no pain, 10= worst possible pain
  • Exudate level moderate to high
  • Ulcer size min 1.6 cm and max 11 cm in any direction
  • Ankle/brachial index >= 0.8
  • Treated with moist wound healing during the past 2 weeks prior to inclusion
  • Adequate compression therapy during the past 2 weeks prior to inclusion
  • The patient is cognitive capable of evaluating his/her pain relief and pain intensity
  • The patient is able to understand the treatment and is willing to comply with the treatment regimen.
  • The patient is able to complete the patient diary
  • The patient is willing and able to give written informed consent

Exclusion Criteria:

  • Painful ulcers that have been treatment resistant to analgesics for the past 6 months or more
  • Pregnant or lactating women
  • Known and verified hypersensitivity to any content of the products used in this investigation
  • Local infection (bacterial imbalanced wound) in the study ulcer
  • Clinical infection in the study ulcer
  • Diseases: Vasculitis, erysipelas and cellulitis of the peri-ulcer skin
  • The investigator considers the patient not eligible
  • Diseases and conditions where ibuprofen or other analgesics are contraindicated (including known hypersensitivity to Aspirin (acetylsalicylic acid) or other analgesics, especially associated with a history of asthma, rhinitis or urticaria)
  • Diabetes
  • Use of per need medication for the past 3 days
  • Concomitant treatment with systemic antibiotics other than nitrofurantoin
  • Concomitant treatment with systemic corticosteroids (more than 10 mg/day prednisolon or equivalent) or other immunosuppressants within 1 month prior to inclusion
  • Concomitant treatment with cancer chemotherapeutics
  • Concomitant participation in other studies
  • Previous participation in this study

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00627094

Aarhus Universitetshospital
Aarhus, Denmark, 8000
Bispebjerg Hospital
Copenhagen, Denmark, 2400
Odense Universitets Hospital
Odense, Denmark, 5000
CHU de Brest
Arras, France, 62000
CHU de Nancy - Hôpital Fournier
Nancy Cedex, France, 54035
Department for Dermatology, University School of Medicine
Essen, Germany, 45122
Georg-August-Universität Göttingen
Göttingen, Germany, 37075
Klinik für Dermatologie und Venerologie
Hannover, Germany, 30449
Universitätsklinikum des Saarlandes
Homburg/Saar, Germany, 66421
Dr. Renzo Bause Praxis
Luedenscheid, Germany, 58511
Fachartzpraxis für Dermatologie, Allergologie, Lasermedizin
Mahlow, Germany, 15831
C.S. SERGAS Rosalía de Castro - Enfermero
Vigo, Pontevedra, Spain, 36201
Hospital de Fuenlabrada
Fuenlabrada, Spain, 28942
Sponsors and Collaborators
Coloplast A/S
Principal Investigator: Karsten Fogh, MD Aarhus University Hospital

Responsible Party: Coloplast A/S Identifier: NCT00627094     History of Changes
Other Study ID Numbers: DK143WS
First Posted: February 29, 2008    Key Record Dates
Results First Posted: February 7, 2017
Last Update Posted: September 15, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases